| CTRI Number |
CTRI/2017/12/011002 [Registered on: 28/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
27/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management in knee pain with Ayurvedic intervention. |
|
Scientific Title of Study
|
A Comparitive Evaluation of Agnikarma and Upanaha in Pain Management in Janusandhigata Vata |
| Trial Acronym |
JSV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Ahalya |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Government Ayurvedic Medical College
Dhanvantari Road
Bangalore
171, 6th Cross, Gandhinagar Bangalore
560009
Bangalore
KARNATAKA
560009
India |
| Phone |
09845458563 |
| Fax |
|
| Email |
ahalyasharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Ahalya |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Government Ayurvedic Medical College
Dhanvantari Road
Bangalore
171, 6th Cross, Gandhinagar Bangalore
560009
KARNATAKA
560009
India |
| Phone |
09845458563 |
| Fax |
|
| Email |
ahalyasharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Ahalya |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic Medical College |
| Address |
Government Ayurvedic Medical College
Dhanvantari Road
Bangalore
171, 6th Cross, Gandhinagar Bangalore
560009
KARNATAKA
560009
India |
| Phone |
09845458563 |
| Fax |
|
| Email |
ahalyasharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Medical College
Dhanvantari Road Bangalore
No monetary support from any source. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR S Ahalya |
Govt Ayurvedic Medical College Dhanvantari Road Bangalore |
Department of PG Studies in Shalya Tantra - OPD room number 6
Bangalore
KARNATAKA |
09845458563
ahalyasharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GAMC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of Knee Joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma |
External application of heated Panchadhatu Shalaka for three sittings at an interval of one week |
| Comparator Agent |
Upanaha churna |
External Application of sufficient quantity of Churna everyday for a period of fifteen days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
pain crepitus and morning stiffness in knee joint lasting for not more than 30 minutes osteophytes on X Ray |
|
| ExclusionCriteria |
| Details |
patients with psoriatic gouty infective Rheumatoid arthritis systemic diseases interferring with treatment strategychronicity less than 6 months and more than 5 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain in knee joint |
Outcomes to be assessed at 7,14,21 and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in Range of Motion and function of the knee joint |
8th 15th 22nd and 52 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Research article in Ayushdhara an international journal of Research in AYUSH &Allied Sciencesyear 2015 volume2 issue1 pages 53 -65 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an Open, Randomized,Controlled Clinical Study to assess the effect of Agnikarma and Upanaha in Pain Management in Osteoarthritis of Knee Joint. The Primary Outcome measures are relief in pain at Baseline 8th 15th 22nd and after completion of one month follow up in cases where there is more than 50% relief noted at the end of 22nd day. The secondary outcome measures are improvement in Range of Motion and functional ability of the Knee Joint |